Sterile drape, instrument attachment set for attaching surgical instrument, and method for attaching surgical instrument to robot arm

ABSTRACT

A sterile drape according to an embodiment may include: a flexible film member including a first opening and a second opening and configured to cover the robot arm received through the second opening; and a resin molded member configured to close the first opening of the flexible film member. The resin molded member includes: an upper surface portion having a shape and a size fitted to an attachment surface of an attachment portion of the robot arm; a side surface portion extending downward from the upper surface portion; and a projection which projects outward from a lower edge of the side surface portion and to which the flexible film member is welded.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to Japanese Patent Application No.2018-159337 filed on Aug. 28, 2018, the entire contents of which areincorporated herein by reference.

TECHNICAL FIELD

One or more embodiments disclosed herein relate to sterile drapes, andparticularly relate to a sterile drape including a flexible film memberhaving an opening and a resin molded member disposed to close theopening of the flexible film member.

BACKGROUND

Sterile drapes including a flexible film member having an opening and aresin molded member disposed to close the opening of the flexible filmmember have been known (see, for example, U.S. Pat. No. 8,142,447).

U.S. Pat. No. 8,142,447 discloses a sterile drape including a flexiblefilm member having an opening and a resin molded member disposed toclose the opening of the flexible film member. The film member isattached to a peripheral portion of the resin molded member. The resinmolded member is in a flat plate-like shape.

In a state in which a robot arm that includes an attachment portionhaving a plurality of drive elements is covered with the film member,the resin molded member of the sterile drape disclosed in U.S. Pat. No.8,142,447 is sandwiched between the attachment portion and an adapterthat includes a plurality of driven elements associated with theplurality of drive elements. The resin molded member is provided with ahole through which a plurality of drive elements are inserted.

SUMMARY

In attaching the sterile drape disclosed in U.S. Pat. No. 8,142,447 tothe robot arm, the flat plate-like resin molded member is positioned atthe attachment portion of the robot arm, and is secured by the adapter.Positioning of the resin molded member is therefore difficult.

One or more embodiments disclosed herein provide a sterile drape whichfacilitates positioning of a resin molded member in attachment.

A sterile drape of one or more embodiments may include a flexible filmmember including a first opening and a second opening and configured tocover the robot arm received through the second opening and a resinmolded member configured to close the first opening of the flexible filmmember, wherein the resin molded member includes an upper surfaceportion having a shape and a size fitted to an attachment surface of theattachment portion, a side surface portion extending downward from theupper surface portion, and a projection which projects outward from alower edge of the side surface portion and to which the flexible filmmember is welded, the upper surface portion, the side surface portion,and the projection being integrally formed, wherein the upper surfaceportion has a plurality of holes at positions corresponding to aplurality of rotating drive sections and a plurality of engagementprojecting portions, the rotating drive sections and the engagementprojecting portions being formed in the attachment portion, and whereinthe adapter includes a plurality of rotated members which correspond tothe plurality of rotating drive sections, and a plurality of engagementrecesses which engage with the plurality of engagement projectingportions. The “upper surface portion” represents a concept of a planewhich faces vertically upward when the resin molded member is placed onthe ground with the projection of the resin molded member touching theground.

An instrument attachment set of one or more embodiments may include anadapter including a plurality of rotated members which correspond to aplurality of rotating drive sections provided in the attachment portion,and a plurality of engagement recesses which correspond to a pluralityof engagement projecting portions provided in the attachment portion,and a sterile drape including a flexible film member including a firstopening and a second opening and configured to cover the robot armreceived through the second opening, and a resin molded memberconfigured to close the first opening of the flexible film member,wherein the resin molded member includes an upper surface portion havinga shape and a size fitted to an attachment surface of the attachmentportion, a side surface portion extending downward from the uppersurface portion, and a projection which projects outward from a loweredge of the side surface portion and to which the flexible film memberis welded, the upper surface portion, the side surface portion, and theprojection being integrally formed, and wherein the upper surfaceportion has a plurality of holes which are disposed at positions thatallow engagement between the plurality of rotating drive sections andthe plurality of rotated members and engagement between the plurality ofengagement projecting portions and the plurality of engagement recesses.

A method for attaching a surgical instrument to a robot arm used in arobotic surgical system according to one or more embodiments mayinclude: preparing a sterile drape including a flexible film memberincluding a first opening and a second opening and configured to coverthe robot arm received through the second opening, and a resin moldedmember configured to close the first opening of the flexible filmmember; attaching the resin molded member to an attachment portion ofthe robot arm which is inserted from the second opening; attaching anadapter via the resin molded member attached to the attachment portion;and attaching the surgical instrument to the adapter, wherein the resinmolded member includes: an upper surface portion having a shape and asize fitted to an attachment surface of the attachment portion; a sidesurface portion extending downward from the upper surface portion; and aprojection which projects outward from a lower edge of the side surfaceportion and to which the flexible film member is welded, the uppersurface portion, the side surface portion, and the projection beingintegrally formed, wherein the adapter includes a plurality of rotatedmembers which correspond to the plurality of rotating drive sections,and a plurality of engagement recesses which engage with the pluralityof engagement projecting portions, and wherein the upper surface portionhas a plurality of holes which are disposed at positions that allowengagement between the plurality of rotating drive sections and theplurality of rotated members and engagement between the plurality ofengagement projecting portions and the plurality of engagement recesses.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram schematically illustrating a robotic surgical systemaccording to an embodiment.

FIG. 2 is a block diagram illustrating a control configuration of therobotic surgical system according to an embodiment.

FIG. 3 is a diagram illustrating a perspective view of the state inwhich a surgical instrument is attached to a robot arm according to anembodiment via an adapter.

FIG. 4 is a diagram illustrating a perspective view of the state inwhich the surgical instrument and the adapter are detached from therobot arm according to an embodiment.

FIG. 5 is a diagram illustrating a perspective view of the adapteraccording to an embodiment as viewed from below.

FIG. 6 is a diagram illustrating a perspective view of the state inwhich a drape is attached to the robot arm according to an embodiment.

FIG. 7 is a diagram illustrating a perspective view of the drapeaccording to an embodiment.

FIG. 8 is a diagram illustrating a perspective view of the state inwhich a resin molded member is about to be attached to an attachmentportion according to an embodiment.

FIG. 9 is a diagram illustrating a plan view of the state in which theresin molded member is attached to the attachment portion according toan embodiment.

FIG. 10 is a diagram illustrating a schematic view of the state in whichan attachment tool according to an embodiment is attached to a proximalend portion of the robot arm.

FIG. 11 is a diagram illustrating a perspective view of the attachmenttool according to an embodiment.

DETAILED DESCRIPTION

One or more embodiments will be described below with reference to thedrawings.

(Configuration of Robotic Surgical System)

Configurations of a robotic surgical system 100 according to anembodiment will be described with reference to FIGS. 1 and 2.

As illustrated in FIG. 1, the robotic surgical system 100 includes aremote control apparatus 10 and a patient-side apparatus 20. The remotecontrol apparatus 10 is used to remotely operate medical equipmentprovided for the patient-side apparatus 20. When an operator O, who is asurgeon, enters a movement type instruction to be executed by thepatient-side apparatus 20 to the remote control apparatus 10, the remotecontrol apparatus 10 transmits the movement type instruction to thepatient-side apparatus 20 via a controller 26. The patient-sideapparatus 20 then handles the medical equipment, such as a surgicalinstrument 40 or an endoscope 50 attached to a robot arm 21, in responseto the movement type instruction transmitted from the remote controlapparatus 10. A minimally invasive operation is performed in thismanner.

The patient-side apparatus 20 constitutes an interface through which asurgery is performed on a patient P. The patient-side apparatus 20 isarranged beside a surgical table 30 on which the patient P lies. Thepatient-side apparatus 20 has a plurality of robot arms 21. An endoscope50 is attached to one of the robot arms 21 (i.e., the robot arm 21(21b)). Surgical instruments 40 are attached to the other robot arms 21(21a). The robot arms 21 are supported by the same platform 23. Each of therobot arms 21 has a plurality of joints. A driving section including aservomotor and a position detector such as an encoder are provided foreach joint. Each robot arm 21 is configured to be controlled such thatthe medical equipment attached to the robot arm 21 makes a desiredmovement in response to a driving signal given via the controller 26.

The platform 23 is supported by a positioner 22 placed on the floor ofthe operating room. The positioner 22 includes a column 24 having alifting shaft adjustable in a vertical direction, and the lifting shaftis coupled to a base 25 having wheels and movable on the floor surface.

The surgical instrument 40 as the medical equipment is detachablyattached to a distal end portion of the robot arm 21 a. The surgicalinstrument 40 includes a housing 43 (see FIG. 4) attached to the robotarm 21 a, an elongated shaft 42 (see FIG. 4), and an end effector 41(see FIG. 4) attached to a distal end portion of the shaft 42. Examplesof the end effector 41 include, but are not limited to, a graspingforceps, scissors, a hook, a high-frequency knife, a snare wire, aclamp, and a stapler, and may include various types of treatment tools.In a surgery using the patient-side apparatus 20, each of the robot arms21 a introduces the surgical instrument 40 into the body of the patientP through a cannula (a trocar) retained on the body surface of thepatient P. The end effector 41 of the surgical instrument 40 is placedin the vicinity of the surgical site.

The endoscope 50 as the medical equipment is detachably attached to adistal end portion of the robot arm 21 b. The endoscope 50 takes imagesin the body cavity of the patient P. The images taken are output to theremote control apparatus 10. Examples of the endoscope 50 include a 3Dendoscope capable of taking three-dimensional images, or a 2D endoscope.In a surgery using the patient-side apparatus 20, the robot arm 21 bintroduces the endoscope 50 into the body of the patient P through atrocar retained on the body surface of the patient P. The endoscope 50is placed in the vicinity of the surgical site.

The remote control apparatus 10 constitutes an interface with theoperator O. The remote control apparatus 10 serves as a device throughwhich the operator O operates the medical equipment attached to eachrobot arm 21. That is, the remote control apparatus 10 is configured tobe capable of transmitting, to the patient-side apparatus 20, themovement type instruction that has been input by the operator O and thatshould be executed by the surgical instrument 40 and the endoscope 50,via the controller 26. The remote control apparatus 10 is installedbeside the surgical table 30 so that the operator can check thecondition of the patient P while operating the master, for example. Theremote control apparatus 10 may be configured, for example, towirelessly transmit the movement type instruction, and may be installedin a room different from the operating room where the surgical table 30is placed.

The term “movement type” to be performed by the surgical instrument 40may refer to the type of movement (a series of positions andorientations) of the surgical instrument 40 and the type of movementexecuted by the function of the respective surgical instruments 40. Forexample, if the surgical instrument 40 is a grasping forceps, themovement type to be performed by the surgical instrument 40 includespositions of rolling and pitching of a wrist of the end effector 41, andopening and closing the jaws. If the surgical instrument 40 is ahigh-frequency knife, the movement type to be executed by the surgicalinstrument 40 may include vibration of the high-frequency knife,specifically, a current supply to the high-frequency knife. If thesurgical instrument 40 is a snare wire, the movement type to beperformed by the surgical instrument 40 may include tightening, andreleasing from the tightening. In addition, the movement type mayinclude a movement of burning off a target site of the surgery, using abipolar or a monopolar to which an electric current is supplied.

Examples of the movement type to be performed by the endoscope 50include positioning, and determination of the orientation, of the tipend of the endoscope 50, or setting of zoom magnification of theendoscope 50.

As illustrated in FIGS. 1 and 2, the remote control apparatus 10includes an operating handle 11, an operation pedal unit 12, a displayunit 13, and a control device 14.

The operating handle 11 is intended to remotely operate the medicalequipment attached to each robot arm 21. Specifically, the operatinghandle 11 accepts the operation conducted by the operator O to controlthe medical equipment (i.e., the surgical instrument 40 and theendoscope 50). The operating handle 11 includes two operating handles 11arranged in the horizontal direction. Specifically, one of the twooperating handles 11 is operated by the right hand of the operator O,and the other operating handle 11 is operated by the left hand of theoperator O.

The operating handle 11 is arranged to extend from the back side to thefront side of the remote control apparatus 10. The operating handle 11is configured to be movable within a predetermined three-dimensionaloperation area A. Specifically, the operating handle 11 is configured tobe movable up and down directions, the leftward and rightwarddirections, and the forward and backward directions.

The remote control apparatus 10 and the patient-side apparatus 20constitute a master-slave system in controlling the movements of therobot arms 21 a and the robot arm 21 b. Specifically, the operatinghandle 11 serves as a master controlling element in the master-slavesystem, and the robot arms 21 a and the robot arm 21 b to which themedical equipment is attached serve as slave moving elements. When theoperator O operates the operating handle 11, the movement of the robotarms 21 a or the robot arm 21 b is controlled so that the distal endportion of each robot arm 21 a (i.e., the end effector 41 of surgicalinstrument 40) or the distal end portion of the robot arm 21 b (i.e.,the endoscope 50) will trace the movement of the operating handle 11 andshift accordingly.

The patient-side apparatus 20 is configured to control the movements ofthe respective robot arms 21 a according to a movement scale factorwhich has been set. For example, in a case in which the movement scalefactor has been set to be ½, the end effector 41 of the surgicalinstrument 40 is controlled to shift by one half (½) of a distance bywhich the operating handle 11 has shifted. As a result, precise surgerycan be accurately performed.

The operation pedal unit 12 includes a plurality of pedals for executingthe function related to the medical equipment. The plurality of pedalsinclude a coagulation pedal, a cutting pedal, a camera pedal, and aclutch pedal. The plurality of pedals are operated by the foot of theoperator O.

The coagulation pedal enables the operation of coagulating the surgicalsite using the surgical instrument 40. Specifically, when thecoagulation pedal is operated, a voltage for coagulation is applied tothe surgical instrument 40, thereby coagulating the surgical site. Thecutting pedal enables the operation of cutting the surgical site usingthe surgical instrument 40. Specifically, when the cutting pedal isoperated, a voltage for the cutting is applied to the surgicalinstrument 40, thereby cutting the surgical site.

The camera pedal is used to change the position and orientation of theendoscope 50 taking images of the body cavity. Specifically, the camerapedal validates the operation of the endoscope 50 through the operatinghandle 11. That is, while the camera pedal is pressed down, the positionand orientation of the endoscope 50 can be changed by using theoperating handle 11. For example, the endoscope 50 is operated usingboth of the left and right operating handles 11. Specifically, theendoscope 50 rotates when the right and left operating handles 11 rotateabout a midpoint between the left and right operating handles 11. Theendoscope 50 moves forward when the left and right operating handles 11are pushed forward. The endoscope 50 moves backward when the left andright operating handles 11 are pulled backward. The endoscope 50 movesup and down, and leftward and rightward when the left and rightoperating handles 11 are moved up and down, and leftward and rightward.

The clutch pedal is used to temporarily block the connection foroperation between the robot arm 21 and the operating handle 11 to stopthe movement of the surgical instrument 40. Specifically, while theclutch pedal is pressed down, the robot arm 21 of the patient-sideapparatus 20 does not move even if the operating handle 11 is moved. Forexample, when the operating handle 11 comes close to the end of themovable range thereof, the clutch pedal is pressed down to temporarilyblock the connection for operation so that the operating handle 11 canbe returned to the center position. When the clutch pedal is no longerpressed down, the robot arm 21 and the operating handle 11 are connectedagain, and the operating handle 11 can be operated again at around thecenter position.

The display unit 13 can display the images taken by the endoscope 50.The display unit 13 includes a scope type display unit or a non-scopetype display unit. The scope type display unit is, for example, adisplay unit which an operator looks into. The non-scope type displayunit represents a concept that includes an open display unit having aflat screen which an operator does not look into, just like a display ofa common personal computer.

In a case in which the scope type display unit is attached, a 3D imagetaken by the endoscope 50 attached to the robot arm 21 b of thepatient-side apparatus 20 is displayed. Also in a case in which thenon-scope type display unit is attached, a 3D image taken by theendoscope 50 provided in the patient-side apparatus 20 is displayed. Inthe case in which the non-scope type display unit is attached, a 2Dimage taken by the endoscope 50 provided in the patient-side apparatus20 may be displayed.

As illustrated in FIG. 2, the control device 14 includes, for example,the control unit 141 including an arithmetic unit such as a CPU, astorage unit 142 including a memory such as a ROM and a RAM, and animage control unit 143. The control device 14 may be comprised of asingle controller which provides centralized control, or may beconfigured as a plurality of controllers which work in cooperation witheach other and provide distributed control. The control unit 141determines whether the movement type instruction input through theoperating handle 11 is a movement type instruction to be executed by therobot arm 21 a, or a movement type instruction to be executed by theendoscope 50, in accordance with the state of the operation pedal unit12. If the control unit 141 determines that the movement typeinstruction input through the operating handle 11 is a movement typeinstruction to be executed by the surgical instrument 40, the controlunit 141 transmits this movement type instruction to the robot arm 21 a.In response, the robot arm 21 a is driven, as a result of which theoperation of the surgical instrument 40 attached to the robot arm 21 ais controlled.

Alternatively, if the control unit 141 determines that the movement typeinstruction input through the operating handle 11 is a movement typeinstruction to be executed by the endoscope 50, the control unit 141transmits the movement type instruction to the robot arm 21 b. Inresponse, the robot arm 21 b is driven, as a result of which theoperation of the endoscope 50 attached to the robot arm 21 b iscontrolled.

The storage unit 142 stores, for example, control programs correspondingto the types of the surgical instrument 40. The control unit 141 readsthe control program in accordance with the type of the surgicalinstrument 40 attached, thereby allowing the movement instructionentered through the operating handle 11 and/or operation pedal unit 12of the remote control apparatus 10 to cause each surgical instrument 40to perform a suitable operation.

The image control unit 143 transmits images taken by the endoscope 50 tothe display unit 13. The image control unit 143 processes or correctsthe image as needed.

(Configurations of Adapter and Attachment Portion)

Configurations of an adapter 60 and an attachment portion 211 accordingto an embodiment will be described with reference to FIGS. 3 to 11.

As illustrated in FIG. 3, the robot arm 21 is covered with a drape 70because the robot arm 21 is used in a clean zone. In an operating room,a cleaning procedure is carried out to prevent surgery incisions andmedical equipment from being infected and contaminated with pathogenicbacteria or foreign substances. A clean zone and a contaminated zone,which is a zone other than the clean zone, are defined in this cleaningprocedure. The surgical site is positioned in the clean zone. Surgeryteam members, including the operator O, take good care so that only adisinfected object is placed in the clean zone during the surgery, andsterilize the object placed in the contaminated zone when it needs to bemoved to the clean zone. Similarly, if the surgery team members,including the operator O, have put their hands in the contaminated zone,they sterilize their hands before they directly touch an object placedin the clean zone. The instrument to be used in the clean zone issterilized, or is covered with a sterilized drape 70. The drape 70 is anexample of a “sterile drape” recited in the claims.

<Attachment Portion>

As illustrated in FIG. 4, the robot arm 21 includes an attachmentportion 211 having an attachment surface 215 and an attachment sidesurface 216, a driving member 212, an engagement projecting portion 213,and a boss 214. The direction in which the attachment portion 211 andthe adapter 60 are arranged is referred to as Z direction. One of the Zdirection is referred to as Z1 direction, and the other is referred toas Z2 direction. The direction in which the robot arm 21 extends isreferred to as Y direction. One of the Y direction is referred to as Y1direction, and the other is referred to as Y2 direction. The Z directionand the Y direction are orthogonal to each other. The directionorthogonal to the Z and Y directions is referred to as X direction. Oneof the X direction is referred to as X1 direction, and the other isreferred to as X2 direction. The Z2 direction is an example of“downward” recited in the claims. The Z direction is an example of a“vertical direction” recited in the claims. The X direction and the Ydirection are an example of a “horizontal direction” recited in theclaims. The boss 214 is an example of an “engagement projecting portion”recited in the claims.

The attachment surface 215 is a surface of the attachment portion 211toward the Z1 direction. The attachment surface 215 has approximately acircular shape when viewed from the Z1 direction. The attachment sidesurface 216 extends from the attachment surface 215 in the Z2 direction.Specifically, the attachment side surface 216 is an inclined surfacethat inclines outward in the radial direction of the attachment surface215 from a peripheral portion of the attachment surface 215 toward theZ2 direction. The attachment surface 215 and the attachment side surface216 of the attachment portion 211 toward the Z1 direction hasapproximately a circular truncated cone shape when viewed from the X1direction.

Each of the driving member 212, the engagement projecting portion 213,and the boss 214 is provided on the attachment surface 215. The drivingmember 212 rotates about rotational axis extending in the Z direction.The driving member 212 includes two first driving members 212 a and twosecond driving members 212 b. In the attachment surface 215, the twofirst driving members 212 a and the two second driving members 212 b arearranged sequentially in the Y2 direction. The driving member 212 is anexample of a “rotating drive section” recited in the claims.

The engagement projecting portion 213 includes a first engagementprojecting portion 213 a, two second engagement projecting portions 213b, and two third engagement projecting portions 213 c. In the attachmentsurface 215, the first engagement projecting portion 213 a, the twosecond engagement projecting portions 213 b, and the two thirdengagement projecting portions 213 c are arranged sequentially in the Y2direction. Each of the first engagement projecting portion 213 a, thetwo second engagement projecting portions 213 b, and the two thirdengagement projecting portions 213 c protrudes in the Z1 direction. Theengagement projecting portion 213 is intended to engage with a pluralityof recesses 67 (see FIG. 5) of the adapter 60, which will be describedlater.

The boss 214 includes a first boss 214 a and a second boss 214 b. Thefirst boss 214 a and the second boss 214 b are disposed in a portion onthe attachment surface 215 toward the Y1 direction. The first boss 214 ais disposed on the side toward X1 direction with respect to the secondboss 214 b. The first boss 214 a and the second boss 214 b are opposedto each other in the X direction. The adapter 60 is attached to theattachment portion 211 of the robot arm 21. The first boss 214 a and thesecond boss 214 b protrude in the Z1 direction.

<Adapter>

The surgical instrument 40 is attached to the adapter 60. The robot arm21 transmits power to the surgical instrument 40 via the adapter 60 inorder to drive the end effector 41 of the surgical instrument 40.

The adapter 60 includes a base 61, a plurality of drive powertransmission members 62, a guide rail 63, a leading guide rail 64, anelectrode array 65, and an arm engagement member 66. As illustrated inFIG. 5, the adapter 60 includes a plurality of recesses 67 and aplurality of positioning holes 68. The drive power transmission members62 are an example of a “rotated member” recited in the claims. Therecesses 67 are an example of an “engagement recess” recited in theclaims.

As illustrated in FIGS. 4 and 5, a first surface 60 a of the adapter 60toward the Z2 direction is attached to the robot arm 21. The surgicalinstrument 40 is attached to a second surface 60 b of the adapter 60toward the Z1 direction. An attachment surface 40 a of the housing 43 ofthe surgical instrument 40 toward the Z2 direction is attached to theadapter 60.

The plurality of drive power transmission members 62 are associated withthe respective driving members 212. The plurality of recesses 67 areassociated with the respective engagement projecting portions 213.

The drive power transmission members 62 are rotatably disposed in thebase 61. Specifically, the drive power transmission members 62 arerotatable about a rotational axis extending in the Z direction. Thedrive power transmission members 62 transmit the rotation of theplurality of driving members 212, which are provided for the attachmentportion 211 of the robot arm 21 a, to the plurality of driven sections(not shown) provided for the surgical instrument 40. A multiple numberof drive power transmission members 62 are provided so as to correspondto the respective driving members 212 of the robot arm 21 a and therespective driven sections (not shown) provided for the surgicalinstrument 40. The plurality of drive power transmission members 62 aredisposed at positions corresponding to the respective driving members212 of the robot arm 21 a and the respective driven sections (not shown)of the surgical instrument 40.

The positioning holes 68 are formed in the first surface 60 a. Thebosses 214 of the robot arm 21 are fitted in the positioning holes 68. Amultiple number of positioning holes 68 are formed. The plurality ofpositioning holes 68 are associated with the respective bosses 214. Thepositioning holes 68 are provided in the vicinity of an edge of thefirst surface 60 a toward the Y1 direction.

(Drape)

As illustrated in FIG. 6, the drape 70 is configured to cover the robotarm 21 used in the robotic surgical system 100. Specifically, asillustrated in FIG. 7, the drape 70 is configured to receive the robotarm 21, and includes a flexible film member 8 having an attachmentopening 8 a, and a resin molded member 9 provided to close theattachment opening 8 a of the flexible film member 8. The attachmentopening 8 a is an example of a “first opening” recited in the claims.

<Flexible Film Member>

The flexible film member 8 has the above-mentioned attachment opening 8a at one end, and an insertion opening 8 b at the other end. That is,the flexible film member 8 has a sleeve-like shape, with one end open bythe attachment opening 8 a and the other end open by the insertionopening 8 b. The flexible film member 8 is made of a resin material suchas thermoplastic polyurethane or polyethylene. The flexible film member8 is formed to be like a thin film.

The attachment opening 8 a has approximately a circular shape whenviewed from the resin molded member 9 side. The diameter of theattachment opening 8 a corresponds to the size of the resin moldedmember 9. The resin molded member 9 is welded to the entire peripheralportion of the attachment opening 8 a. The insertion opening 8 b hasapproximately a circular shape when viewed from the side opposite to theresin molded member 9. The diameter of the insertion opening 8 b islarger than that of attachment opening 8 a. The insertion opening 8 b islarge enough to receive the robot arm 21 into the flexible film member8.

<Resin Molded Member>

As illustrated in FIG. 8, the resin molded member 9 of an embodiment hasa shape corresponding to the contour of the attachment portion 211.Specifically, the resin molded member 9 includes an upper surfaceportion 9 a having a shape and a size fitted to the attachment surface215 of the attachment portion 211, a side surface portion 9 b extendingfrom the upper surface portion 9 a in the Z2 direction, and a projection9 c which projects outward from the edge, in the Z2 direction, of theside surface portion 9 b (i.e., the lower edge) and to which theflexible film member 8 is welded. These portions are integrally formed.

The resin molded member 9 is properly positioned by the upper surfaceportion 9 a and the side surface portion 9 b by simply attaching theresin molded member 9 to the attachment portion 211 of the robot arm 21.This configuration facilitates the positioning of the resin moldedmember 9 in attachment. In addition, the movement of the resin moldedmember 9 associated with the movement of the robot arm 21 is restrictedby the side surface portion 9 b extending downward from the uppersurface portion 9 a which has the shape and size fitted to theattachment surface 215 of the attachment portion 211. Misalignment ofthe resin molded member 9 can thus be reduced. Further, the projection 9c facilitates the welding of the resin molded member 9 and the flexiblefilm member 8 to each other.

The upper surface portion 9 a and the side surface portion 9 b of theresin molded member 9 have the shape and size corresponding to theattachment surface 215 of the attachment portion 211 and the attachmentside surface 216 extending downward from the attachment surface 215,respectively. Thus, even when the resin molded member 9 is about to makea relative movement with respect to the attachment portion 211 of therobot arm 21, misalignment of the resin molded member 9 is less likelyto occur because the side surface portion 9 b of the resin molded member9 is in contact with the attachment side surface 216 of the attachmentportion 211 of the robot arm 21.

Specifically, the upper surface portion 9 a and the side surface portion9 b of the resin molded member 9 form approximately a circular truncatedcone shape when viewed from the X1 direction. This configuration allowsthe resin molded member 9 to have a shape that is more fitted to theattachment portion 211 of the robot arm 21. Misalignment of the resinmolded member 9 can thus be reduced more reliably.

The resin molded member 9 is made of a resin material such aspolyethylene terephthalate. The resin molded member 9 has a flatplate-like shape.

<Upper Surface Portion>

Similarly to the attachment surface 215 of the attachment portion 211,the upper surface portion 9 a has approximately a circular shape whenviewed from the Z1 direction. The diameter of the upper surface portion9 a is substantially the same as the diameter of the attachment surface215 of the attachment portion 211. Thus, the upper surface portion 9 ais layered on (overlaps with) the attachment surface 215 of theattachment portion 211 when viewed from the Z1 direction. As illustratedin FIG. 4, the upper surface portion 9 a (see FIG. 8) is sandwichedbetween the adapter 60 and the attachment portion 211 of the robot arm21. On the other hand, the side surface portion 9 b (see FIG. 8) and theprojection 9 c (see FIG. 8) are not sandwiched between the adapter 60and the attachment portion 211 of the robot arm 21.

<Insertion Through Hole>

As illustrated in FIG. 9, the upper surface portion 9 a has a plurality(i.e., six) of insertion through holes 91 at positions corresponding tothe plurality (i.e., four) of the driving members 212, the plurality(i.e., five) of engagement projecting portions 213, and the plurality(i.e., two) of bosses 214. That is, the insertion through holes 91 areformed in the upper surface portion 9 a so as to correspond to the twofirst driving members 212 a, two second driving members 212 b, the firstengagement projecting portion 213 a, two second engagement projectingportions 213 b, and two third engagement projecting portions 213 c. Theinsertion through holes 91 are formed in the upper surface portion 9 aso as to further correspond to the first boss 214 a and the second boss214 b.

This configuration contributes to reducing the area of a portion of theupper surface portion 9 a of the resin molded member 9 where theinsertion through holes 91 are formed, compared to the case in which theresin molded member 9 is provided with one insertion through hole toreceive all of the plurality of driving members 212, the plurality ofengagement projecting portions 213, and the plurality of bosses 214. Itis therefore possible to substantially prevent a decrease in thestrength of the resin molded member 9.

The plurality of insertion through holes 91 include a shared hole 92which corresponds to both of at least one of the plurality of drivingmembers 212 and at least one of the plurality of engagement projectingportions 213. That is, the shared hole 92 is a hole used in common toreceive both of the driving member 212 and the engagement projectingportion 213. The shared hole 92 formed in the upper surface portion 9 aof the resin molded member 9 contributes to reducing the number ofinsertion through holes 91 formed in the upper surface portion 9 a ofthe resin molded member 9, which facilitates the fabrication of theresin molded member 9.

Specifically, the shared hole 92 includes a first shared hole 92 acorresponding to one of the two first driving members 212 a toward theX1 direction and one of the two second engagement projecting portions213 b toward the X1 direction. The shared hole 92 includes a secondshared hole 92 b corresponding to one of the two first driving members212 a toward the X2 direction and one of the two second engagementprojecting portions 213 b toward the X2 direction. The shared hole 92includes a third shared hole 92 c corresponding to the two seconddriving members 212 b and the two third engagement projecting portions213 c.

The plurality of insertion through holes 91 include dedicated holes 93which respectively correspond to one of the plurality of engagementprojecting portions 213 and one of the plurality of bosses 214. That is,the dedicated holes 93 are holes used to receive the respectiveengagement projecting portions 213 and the bosses 214 independently fromeach other. The dedicated holes 93 formed in the upper surface portion 9a of the resin molded member 9 in addition to the shared hole 92contribute to reducing an increase in complexity of the shape of therespective insertion through holes 91 formed in the upper surfaceportion 9 a of the resin molded member 9. It is therefore possible tofacilitate the fabrication of the resin molded member 9.

Specifically, the dedicated holes 93 include a first dedicated hole 93 acorresponding to the first engagement projecting portion 213 a. Thededicated holes 93 include a second dedicated hole 93 b corresponding tothe first boss 214 a. The dedicated holes 93 include a third dedicatedhole 93 c corresponding to the second boss 214 b.

The total number of the plurality (i.e., four) of driving members 212,the plurality (i.e., five) of engagement projecting portions 213, andthe plurality (i.e., two) of bosses 214 is 11. The number of theplurality (i.e., six) of insertion through holes 91 is 6. That is, thenumber of the plurality of insertion through holes 91 is less than thetotal number of the plurality of driving members 212, the plurality ofengagement projecting portions 213, and the plurality of bosses 214. Itis therefore possible to fabricate the resin molded member 9 more easilythan in the case in which the plurality of insertion through holes 91corresponding to the total number of the plurality of driving members212 and the plurality of engagement projecting portions 213 are formedin the upper surface portion 9 a.

<Side Surface Portion>

As illustrated in FIGS. 8 and 9, the side surface portion 9 b hassubstantially an annular shape when viewed from the Z1 direction. Theside surface portion 9 b is provided along the entire peripheral portionof the upper surface portion 9 a. The side surface portion 9 b is aninclined surface that inclines inward in the radial direction of theupper surface portion 9 a toward the Z1 direction, as viewed from the X1direction. That is, the edge of the side surface portion 9 b toward theZ1 direction is inside the edge of the side surface portion 9 b towardthe Z2 direction with respect to the radial direction of the uppersurface portion 9 a.

The length L1 of the side surface portion 9 b along the verticaldirection is smaller than the diameter of the upper surface portion 9 a.Specifically, the length L1 of the side surface portion 9 b along thevertical direction is one sixth (⅙) or more and a half (½) or less ofthe maximum length L2 of the upper surface portion 9 a in the Xdirection (Y direction). The length L1 of the side surface portion 9 balong the vertical direction is the distance in the Z direction betweenthe edge of the side surface portion 9 b toward the Z2 direction and theedge of the side surface portion 9 b toward the Z1 direction. Thisconfiguration makes the resin molded member 9 have a flat shape, whichmeans that the resin molded member 9 can be compact in size in thevertical direction. The space for accommodating the drape 70 can thus bereduced.

The length L1 of the side surface portion 9 b along the verticaldirection is approximately a half of the length L3 of the attachmentportion 211 in the Z direction.

<Projection>

As illustrated in FIGS. 8 and 9, the projection 9 c has substantially anannular shape when viewed from the Z1 direction. The projection 9 cprotrudes outward in the radial direction of the upper surface portion 9a from the side surface portion 9 b. The projection 9 c is providedalong the entire peripheral portion of the edge of the side surfaceportion 9 b toward the Z2 direction. The projection 9 c has apredetermined width W in the radial direction of the upper surfaceportion 9 a. The predetermined width W is large enough to weld the rimof the attachment opening 8 a of the flexible film member 8.

<Attachment Tool>

As illustrated in FIG. 10, the flexible film member 8 is attached to theproximal end portion 217 of the robot arm 21 by the attachment tool 1.This configuration makes it less likely that the attachment tool 1inhibits the movement of the joints of the robot arm 21, as compared tothe case in which the attachment tool 1 is attached to a position otherthan the proximal end portion 217 of the robot arm 21, thereby making itpossible to maintain the appropriate movement of the robot arm 21.

Specifically, as illustrated in FIGS. 10 and 11, the attachment tool 1includes an insertion portion 1 a to be fitted in a groove 217 a formedin the proximal end portion 217 of the robot arm 21, and a knob 1 b forattaching and detaching the insertion portion 1 a to and from the groove217 a formed in the proximal end portion 217 of the robot arm 21. Theinsertion portion 1 a has approximately an arc shape along the groove217 a formed in the proximal end portion 217 of the robot arm 21. Theknob 1 b protrudes outward in the radial direction of the insertionportion 1 a from an outer circumferential surface 1 c in the radialdirection of the insertion portion 1 a. The knob 1 b is arranged in themiddle, in the circumferential direction, of the insertion portion 1 aon the outer circumferential surface 1 c in the radial direction of theinsertion portion 1 a.

The insertion portion 1 a and the knob 1 b are formed integrally. Theinsertion portion 1 a and the knob 1 b are made of resin.

(Variations)

One or more embodiments disclosed herein are meant to be illustrative inall respects and should not be construed to be limiting in any manner.The scope of one or more embodiments disclosed herein is defined not bythe above-described embodiments, but by the scope of claims, andincludes all modifications (variations) within equivalent meaning andscope to those of the claims.

For example, an example in which the dedicated holes 93 correspond toone of the plurality of engagement projecting portions 213 and one ofthe plurality of bosses 214 has been described in the above embodiment,but this is a non-limiting example. In one or more embodiments disclosedherein, the dedicated hole may correspond to one of the plurality ofdriving members (i.e., rotating drive sections).

An example in which six insertion through holes 91 are formed in theupper surface portion 9 a has been described in the above embodiment,but this is a non-limiting example. In one or more embodiments, one tofive, or seven or more insertion through holes may be formed.

An example in which the number of the plurality of engagement projectingportions 213 is five has been described in the above embodiment, butthis is a non-limiting example. In one or more embodiments, two to four,or six or more engagement projecting portions may be provided.

An example in which the number of the plurality of bosses 214 is two hasbeen described in the above embodiment, but this is a non-limitingexample. In one or more embodiments, three or more bosses may beprovided.

An example in which the number of the plurality of driving members 212is four has been described in the above embodiment, but this is anon-limiting example. In one or more embodiments, two to three, or fiveor more driving members (rotating drive sections) may be provided.

An example in which the upper surface portion 9 a and the side surfaceportion 9 b of the resin molded member 9 form approximately a circulartruncated cone shape when viewed from the X1 direction has beendescribed in the above embodiment, but this is a non-limiting example.In one or more embodiments, the shape may be any shape as long as theportions 9 a and 9 b are fitted to the shape of the attachment portionof the robot arm, and may be a columnar shape or the like.

An example in which the length L1 of the side surface portion 9 b alongthe vertical direction is one sixth (⅙) or more and a half (½) or lessof the maximum length L2 of the upper surface portion 9 a in the Xdirection (Y direction) has been described in the above embodiment, butthis is a non-limiting example. In one or more embodiments, the lengthof the side surface portion along the vertical direction may be lessthan one sixth (⅙) or greater than a half (½) of the maximum length ofthe upper surface portion in the X direction (Y direction).

An example in which the number of the plurality of insertion throughholes 91 is less than the total number of the plurality of drivingmembers 212, the plurality of engagement projecting portions 213, andthe plurality of bosses 214 has been described in the above embodiment,but this is a non-limiting example. In one or more embodiments, thenumber of the plurality of insertion through holes may be the same asthe total number of the plurality of driving members, the plurality ofengagement projecting portions, and the plurality of bosses.

An example in which the plurality of insertion through holes 91 includesboth of the shared hole 92 and the dedicated hole 93 has been describedin the above embodiment, but this is a non-limiting example. In one ormore embodiments, the plurality of insertion through holes may includeonly the shared holes, or only the dedicated holes.

An example in which the flexible film member 8 is attached to theproximal end portion 217 of the robot arm 21 by the attachment tool 1has been described in the above embodiment, but this is a non-limitingexample. In one or more embodiments, the flexible film member may beattached to any portion of the robot arm other than the proximal endportion by the attachment tool.

An example in which the first shared hole 92 a corresponds to the firstdriving member 212 a toward the X1 direction and the second engagementprojecting portion 213 b toward the X1 direction, and the second sharedhole 92 b corresponds to the first driving member 212 a toward the X2direction and the second engagement projecting portion 213 b toward theX2 direction has been described in the above embodiment, but this is anon-limiting example. In one or more embodiments, the upper surfaceportion may be provided with a shared hole that corresponds to both of:the first driving member toward the X1 direction and the secondengagement projecting portion toward the X1 direction; and the firstdriving member toward the X2 direction and the second engagementprojecting portion toward the X2 direction.

The invention claimed is:
 1. A sterile drape to be attached to anattachment portion of a robot arm used in a robotic surgical system, viaan adapter for attachment of a surgical instrument, the sterile drapecomprising: a flexible film member including a first opening and asecond opening and configured to cover the robot arm received throughthe second opening; and a resin molded member configured to close thefirst opening of the flexible film member, wherein the resin moldedmember includes: an upper surface portion having a shape and a sizefitted to an attachment surface of the attachment portion; a sidesurface portion extending downward from the upper surface portion; and aprojection which projects outward from a lower edge of the side surfaceportion and to which the flexible film member is welded, the uppersurface portion, the side surface portion, and the projection beingintegrally formed, wherein the upper surface portion has a plurality ofholes at positions corresponding to a plurality of rotating drivesections and a plurality of engagement projecting portions, the rotatingdrive sections and the engagement projecting portions being formed inthe attachment portion, and wherein the adapter includes a plurality ofrotated members which correspond to the plurality of rotating drivesections, and a plurality of engagement recesses which engage with theplurality of engagement projecting portions; wherein the plurality ofholes include a shared hole which corresponds to both at least one ofthe plurality of rotating drive sections and at least one of theplurality of engagement projecting portions.
 2. The sterile drape ofclaim 1, wherein the side surface portion of the resin molded member hasa size and a shape corresponding to an attachment side surface extendingdownward from the attachment surface.
 3. The sterile drape of claim 1,wherein the resin molded member has a circular truncated cone shape. 4.The sterile drape of claim 1, wherein a length of the side surfaceportion along a vertical direction is one sixth (⅙) or more and a half(½) or less of a maximum length of the upper surface portion in ahorizontal direction.
 5. The sterile drape of claim 1, wherein thenumber of the plurality of holes is less than a total number of theplurality of rotating drive sections and the plurality of engagementprojecting portions.
 6. The sterile drape of claim 5, wherein theplurality of holes include a dedicated hole which corresponds to one ofthe plurality of rotating drive sections or one of the plurality ofengagement projecting portions.
 7. The sterile drape of claim 1, whereinthe flexible film member is attached to a proximal end portion of therobot arm by an attachment tool at a position of the flexible filmmember closer to the second opening than to the first opening.
 8. Aninstrument attachment set for attaching a surgical instrument to anattachment portion of a robot arm in a robotic surgical system, theinstrument attachment set comprising: an adapter including a pluralityof rotated members which correspond to a plurality of rotating drivesections provided in the attachment portion, and a plurality ofengagement recesses which correspond to a plurality of engagementprojecting portions provided in the attachment portion; and a steriledrape including: a flexible film member including a first opening and asecond opening and configured to cover the robot arm received throughthe second opening; and a resin molded member configured to close thefirst opening of the flexible film member, wherein the resin moldedmember includes: an upper surface portion having a shape and a sizefitted to an attachment surface of the attachment portion; a sidesurface portion extending downward from the upper surface portion; and aprojection which projects outward from a lower edge of the side surfaceportion and to which the flexible film member is welded, the uppersurface portion, the side surface portion, and the projection beingintegrally formed, and wherein the upper surface portion has a pluralityof holes which are disposed at positions that allow engagement betweenthe plurality of rotating drive sections and the plurality of rotatedmembers and engagement between the plurality of engagement projectingportions and the plurality of engagement recesses; wherein the pluralityof holes include: a shared hole which corresponds to both of at leastone of the plurality of rotating drive sections and at least one of theplurality of engagement projecting portions; and a dedicated hole whichcorresponds to one of the plurality of rotating drive sections or one ofthe plurality of engagement projecting portions.
 9. The instrumentattachment set of claim 8, wherein the side surface portion of the resinmolded member has a size and a shape corresponding to an attachment sidesurface extending downward from the attachment surface.
 10. Theinstrument attachment set of claim 8, wherein the resin molded memberhas a circular truncated cone shape.
 11. The instrument attachment setof claim 8, wherein a length of the side surface portion along avertical direction is one sixth (⅙) or more and a half (½) or less of amaximum length of the upper surface portion in a horizontal direction.12. The instrument attachment set of claim 8, wherein the number of theplurality of holes is less than a total number of the plurality ofrotating drive sections and the plurality of engagement projectingportions.